The main problem in peritoneal dialysis treatment is that of infections: their frequent consequences are hospitalization, “wearing out” of the peritoneal membrane owing to sepsis and cessation (drop-out) of the methodology.
To date, moreover, there is still no perfect “anticontamination” device: the German company Fresenius Medical Care has introduced a disposable peritoneal exchange device but this leaves open a window of potential infective contamination for approx. 50% of the total risk relative to exchange in manual ambulatory peritoneal dialysis (CAPD).
As the lines in which the dialysis solution flows are sterile and disposable, this risk is connected with the two moments of connection and disconnection of said lines.
Among the various solutions proposed by the manufacturers of equipment for peritoneal dialysis, mention is made of the company Fresenius Medical Care, which has attempted to eliminate the risk of contamination during connection, by devising a closing means, called “pin” here (a kind of sealing plug with O-ring seal), which a disposable cylindrical device with an operating handle pushes inside the lumen of the peritoneal catheter at the end of the peritoneal dialysis cycle. As this takes place with the catheter connected to the device, on disconnection of the peritoneal catheter from the device it is not possible for bacteria, viruses and other contaminating material to get into the catheter. However, before beginning the next cycle it is necessary to extract the used pin from the end of the catheter, before connecting to a new disposable device equipped with a new end-of-cycle pin. This extraction is carried out with suitable plugs with retaining clips which, screwed onto the end of the catheter, hook the used pin and, once unscrewed, extract it. This operation, performed in the open air by the patient's hands, again exposes him to the risk of contamination, and the more serious risk of peritonitis.
Another device is described in U.S. Pat. No. 6,485,483. Other devices for peritoneal dialysis which tackle the problem of contamination are described in U.S. Pat. No. 5,221,267, DE 10042067, U.S. Pat. No. 5,336,173, EP 0 092 528, U.S. Pat. No. 4,950,230 and GB 2 134 202.
The present invention sets itself the aim of completely or substantially eliminating the risk of peritonitis.
Because the choice of the methodology is still subordinated to pressing social conditions, for a patient of low socioeconomic level (deficient hygiene, scant domiciliary area for providing a “controlled contamination” zone, insufficient cultural level or conditions of poor vigilance connected with age) this methodology will easily be proscribed, for reasons not primarily connected with the patient's condition, but relating to the safety of the methodology.
The aim ought to be achieved in the device rather than on the patient: since peritoneal dialysis is a health methodology for problems that are statistically more frequent in the third and fourth age, thus at times when the patient's compliance—both physical and mental—is often poor, we ought to prescind from considering the patient's contribution when planning the objectives of sterility, simplicity of use and safety. All of the objectives ought to be achieved by the device itself.
Therefore it is still felt that there is a great need for a connector for manual ambulatory peritoneal dialysis that would ensure sterility in the operations of manipulation of the dialysis device, that is both easy to use, especially for patients with poor dexterity and/or low level of training in hygiene and that would not require the assistance of specialized personnel.